蔓越莓与抗生素预防尿路感染：一项针对绝经前女性的随机双盲非劣效性试验。
Cranberries vs antibiotics to prevent urinary tract infections: a randomized double-blind noninferiority trial in premenopausal women.
作者信息
Beerepoot Mariëlle A J, ter Riet Gerben, Nys Sita, van der Wal Willem M, de Borgie Corianne A J M, de Reijke Theo M, Prins Jan M, Koeijers Jeanne, Verbon Annelies, Stobberingh Ellen, Geerlings Suzanne E
机构信息
Division of Infectious Diseases, Tropical Medicine & AIDS, Department of Internal Medicine, Academic Medical Center, Amsterdam, the Netherlands.
出版信息
Arch Intern Med. 2011 Jul 25;171(14):1270-8. doi: 10.1001/archinternmed.2011.306.
BACKGROUND
The increasing prevalence of uropathogens resistant to antimicrobial agents has stimulated interest in cranberries to prevent recurrent urinary tract infections (UTIs).
METHODS
In a double-blind, double-dummy noninferiority trial, 221 premenopausal women with recurrent UTIs were randomized to 12-month prophylaxis use of trimethoprim-sulfamethoxazole (TMP-SMX), 480 mg once daily, or cranberry capsules, 500 mg twice daily. Primary end points were the mean number of symptomatic UTIs over 12 months, the proportion of patients with at least 1 symptomatic UTI, the median time to first UTI, and development of antibiotic resistance in indigenous Escherichia coli.
RESULTS
After 12 months, the mean number of patients with at least 1 symptomatic UTI was higher in the cranberry than in the TMP-SMX group (4.0 vs 1.8; P = .02), and the proportion of patients with at least 1 symptomatic UTI was higher in the cranberry than in the TMP-SMX group (78.2% vs 71.1%). Median time to the first symptomatic UTI was 4 months for the cranberry and 8 months for the TMP-SMX group. After 1 month, in the cranberry group, 23.7% of fecal and 28.1% of asymptomatic bacteriuria E coli isolates were TMP-SMX resistant, whereas in the TMP-SMX group, 86.3% of fecal and 90.5% of asymptomatic bacteriuria E coli isolates were TMP-SMX resistant. Similarly, we found increased resistance rates for trimethoprim, amoxicillin, and ciprofloxacin in these E coli isolates after 1 month in the TMP-SMX group. After discontinuation of TMP-SMX, resistance reached baseline levels after 3 months. Antibiotic resistance did not increase in the cranberry group. Cranberries and TMP-SMX were equally well tolerated.
CONCLUSION
In premenopausal women, TMP-SMX, 480 mg once daily, is more effective than cranberry capsules, 500 mg twice daily, to prevent recurrent UTIs, at the expense of emerging antibiotic resistance.
TRIAL REGISTRATION
isrctn.org Identifier: ISRCTN50717094.
背景
对抗菌药物耐药的尿路病原体患病率不断上升，引发了人们对蔓越莓预防复发性尿路感染（UTI）的兴趣。
方法
在一项双盲、双模拟非劣效性试验中，221名患有复发性UTI的绝经前女性被随机分为两组，一组每天一次服用480毫克甲氧苄啶-磺胺甲恶唑（TMP-SMX）进行为期12个月的预防性治疗，另一组每天两次服用500毫克蔓越莓胶囊。主要终点指标包括12个月内有症状UTI的平均次数、至少发生1次有症状UTI的患者比例、首次发生UTI的中位时间以及本土大肠杆菌中抗生素耐药性的发展情况。
结果
12个月后，蔓越莓组中至少发生1次有症状UTI的患者平均次数高于TMP-SMX组（4.0次对1.8次；P = 0.02），且蔓越莓组中至少发生1次有症状UTI的患者比例高于TMP-SMX组（78.2%对71.1%）。蔓越莓组首次出现有症状UTI的中位时间为4个月，TMP-SMX组为8个月。1个月后，蔓越莓组中23.7%的粪便和28.1%的无症状菌尿大肠杆菌分离株对TMP-SMX耐药，而在TMP-SMX组中，86.3%的粪便和90.5%的无症状菌尿大肠杆菌分离株对TMP-SMX耐药。同样，我们发现TMP-SMX组在1个月后这些大肠杆菌分离株对甲氧苄啶、阿莫西林和环丙沙星的耐药率增加。停用TMP-SMX后，3个月后耐药性恢复到基线水平。蔓越莓组的抗生素耐药性没有增加。蔓越莓和TMP-SMX的耐受性相当。
结论
对于绝经前女性，每天一次服用480毫克TMP-SMX预防复发性UTI比每天两次服用500毫克蔓越莓胶囊更有效，但代价是会出现抗生素耐药性。
试验注册
isrctn.org标识符：ISRCTN50717094。
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